GenScript · 1 month ago
CMC Analytical Scientist
United States
Full-time
Remote
Mid, Senior Level
$80K/yr - $110K/yr
3+ years expGenScript Biotech Corporation is a global biotechnology group committed to making humans and nature healthier through biotechnology. The CMC Analytical Scientist role involves supporting the development and maintenance of a GMP QC-Analytics Lab, optimizing molecular and cellular assays, and ensuring compliance with regulatory standards to enhance manufacturing capabilities for clinical trial materials.
BiotechnologyLife ScienceManufacturingGenetics
Responsibilities
Support the set-up, development and maintenance of a GMP QC-Analytics Lab
Generate and characterize engineered cell lines, including production of MCB and WCB for cell-based assay development
Develop, optimize, and execute molecular and cellular assays to assess vector performance using qPCR/ddPCR based assay, Western blot, ELISA and Flow cytometry
Independently plan, perform, analyze, and interpret experiments, present clear data summaries and recommendations to cross-functional teams and clients
Prepare technical reports, study summaries, and presentation materials to support decision-making
Collaborate closely with other teams in CMC and coordinate cross-functional activities to support tech transfer and CMC activities
Drive continuous improvement by identifying and implementing new tools, technologies, and best practices in CGT CMC analytics
Ensure compliance with BSL-2 biosafety standards, cGMP, and applicable regulatory requirements
Qualification
Required
Ph.D. with 2+ years or M.S. with 3+ years in Molecular Biology, Cell & Gene Therapy, Biochemistry, or related field
Demonstrated hands-on experience in lentiviral vector release testing and characterization (required)
Expertise in molecular and cell biology techniques, including qPCR, ddPCR, ELISA or DNA Sequencing/Analysis
Hands-on experience with Western blotting and flow cytometry for protein and cell-based analyses
Working knowledge of Good Documentation Practices, data integrity, and ALCOA+ principles
Strong problem-solving skills with the ability to work independently and collaboratively in a team environment
Excellent interpersonal, verbal, and written communication skills
Familiarity with regulatory requirements and guidance from agencies such as FDA and ICH
Preferred
Exposure to NGS-based methods for vector or genome characterization is a plus
Experience with EU Annex 1 and laboratory audits is a plus
Company
GenScript
GenScript USA, Inc. is a leading contract research organization (CRO) specialized in biological research and drug discovery/development
5001-10000 employees
H1B Sponsorship
GenScript has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
30%
Represents job field similar to this job
Engineering and Development
Sales
Customer Service and Support
Marketing
Management and Executive
Product Management
Accounting and Finance
Human Resources
Legal and Compliance
Trends of Total Sponsorships
*2026 (6)
2025 (37)
2024 (27)
2023 (19)
2022 (11)
2021 (11)
2020 (12)
Funding
Current Stage
Public CompanyTotal Funding
unknown2015-12-31IPO
Leadership Team
Larry Wang
Co-Founder & Board Director
Shiniu Wei
Chief Financial Officer
Recent News
South China Morning Post
2026-06-03
PR Newswire UK
2026-05-12
Company data provided by crunchbase